System, Nuclear Magnetic Resonance Imaging

Product Code: LNH

Radiology Nuclear Magnetic Resonance Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 892.1000


Radiation TypeMicrowave EMF
Radition SafetyNone
Annual ReportsNo

Products Classified as LNH

5388System, Nuclear Magnetic Resonance ImagingMagnetic Resonance Diagnostic Device.

Total Product Life Cycle (TPLC) Devices

5388System, Nuclear Magnetic Resonance ImagingMagnetic Resonance Diagnostic Device.

FDA Consensus Standards

System, Nuclear Magnetic Resonance Imaging [33222]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [37168]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [37048]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [35654]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [34007]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [33534]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [38515]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [32083]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [29948]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [33533]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [33531]21 CFR §892.1000 🔎
System, Nuclear Magnetic Resonance Imaging [33541]21 CFR §892.1000 🔎

Pre-market Notifications for LNH

K223079StageSpinTech, Inc.
K222387Vantage Galan 3T, MRT-3020, V8.0 With AiCE Reconstruction Processing Unit For MRCanon Medical Systems Corporation
K221923Swoop Portable MR Imaging SystemHyperfine, Inc.
K221393Swoop Portable MR Imaging SystemHyperfine, Inc.
K221025I_ Field 1.5T Superconducting Magnetic Resonance Imaging SystemMRI Division,Beijing Wandong Medical Technology Co.,Ltd.
K220939MAGNETOM Lumina And MAGNETOM Vida Fit With Syngo MR XA50ASiemens Medical Solutions USA Inc.
K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.
K220575MAGNETOM Free.Max, MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.
K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.
K220332UMR Omega With UWS-MR-MRSShanghai United Imaging Healthcare Co.,Ltd.
K220192Vantage Galan 3T, MRT-3020, V8.0 With AiCE Reconstruction Processing Unit For MRCanon Medical Systems Corporation
K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.
K220018MR Elastography; MZEK-001ACanon Medical Systems Corporation
K213717AIR Recon DLGE Medical Systems,LLC (GE Healthcare)
K213693MAGNETOM Vida With Syngo MR XA50ASiemens Medical Solutions USA, Inc.

Global Unique Device Identification Database

00613994719232System, nuclear magnetic resonance imaging
00613994719225System, nuclear magnetic resonance imaging
00613994703125System, nuclear magnetic resonance imaging
00613994703118System, nuclear magnetic resonance imaging
00613994670083System, nuclear magnetic resonance imaging
00613994670069System, nuclear magnetic resonance imaging
00613994670052System, nuclear magnetic resonance imaging
00613994532107System, nuclear magnetic resonance imaging
00613994532091System, nuclear magnetic resonance imaging
00613994532053System, nuclear magnetic resonance imaging
00613994532046System, nuclear magnetic resonance imaging
00613994532039System, nuclear magnetic resonance imaging
00613994532022System, nuclear magnetic resonance imaging
00613994505002System, nuclear magnetic resonance imaging
00613994463067System, nuclear magnetic resonance imaging

Maude Adverse Events

GE 1.5T SIGNA HDX MR SYSTEMGE MEDICAL SYSTEMS, LLC2020-03-31
INGENIA ELITION XPHILIPS MEDICAL SYSTEMS NEDERLAND B. V.2020-03-27
GENERAL ELECTRICGE MEDICAL SYSTEMS, LLC2020-03-20
MRISYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGINGUNKNOWN2020-03-19
INGENIA 1.5TPHILIPS ELECTRONICS NEDERLAND B.V.2020-03-17
GE ARCHITECTGE HEALTHCARE MANUFACTURING LLC.2020-03-12
GE 1.5T SIGNA HDX MR SYSTEMGE MEDICAL SYSTEMS, LLC2020-03-12
DISCOVERY MR750W 3.0TGE MEDICAL SYSTEMS, LLC2020-03-11
MAGNETOM SKYRASIEMENS HEALTHCARE GMBH- MR2020-02-28
MAGNETOM ESSENZASIEMENS SHENZHEN MAGNETIC RESONANCE LTD.2020-02-26
ACHIEVA 1.5T NEWPHILIPS ELECTRONICS NEDERLAND B.V.2020-02-25
MAGNETOM SYMPHONY SYNGO MRSIEMENS HEALTHCARE GMBH- MR2020-02-20
INGENIA ELITION XPHILIPS ELECTRONICS NEDERLAND B.V.2020-02-19
QUADRATURE LOWER EXTREMITY COILINVIVO CORPORATION2020-02-10
ACHIEVA XR 1.5T/3.0TPHILIPS HEALTHCARE2020-02-05
MAGNETOM SOLASIEMENS HEALTHCARE GMBH- MR2020-02-04
GE 1.5T SIGNA HDX MR SYSTEMGE MEDICAL SYSTEMS, LLC2020-01-28
TESLA 1.5 MRIUNK2020-01-24
MAGNETOM AERASIEMENS HEALTHCARE GMBH- MR2020-01-20
ACHIEVA 1.5T NEWPHILIPS HEALTHCARE2020-01-20
MAGNETOM AVANTO FITSIEMENS HEALTHCARE GMBH- MR2020-01-17
SIGNA PIONEERGE MEDICAL SYSTEMS, LLC2020-01-15
SIGNA PIONEERGE MEDICAL SYSTEMS, LLC2020-01-15
MRI MACHINEUNK2020-01-14
CANONCANON MEDICAL SYSTEMS CORPORATION2020-01-14
GE MRI MACHINE - ARTISTGENERAL ELECTRIC CO.2020-01-10
1.5T QUADRATURE LOWER EXTREMITY COILINVIVO CORPORATION2020-01-09
SIEMENS AERA MRI UNITSIEMENS AG / SIEMENS HEALTHCARE GMBH2020-01-06
DISCOVERY MR750W 3.0TGE MEDICAL SYSTEMS, LLC2020-01-03
MAGNETOM SKYRA FITSIEMENS HEALTHCARE GMBH2019-11-27
ACHIEVA 1.5T NEWPHILIPS HEALTHCARE2019-11-26
1.5T SIGNA HDXTGE MEDICAL SYSTEMS, LLC2019-11-21
MAGNETOM AVANTO DOTSIEMENS HEALTHCARE GMBH2019-11-20
MAGNETOM ESPREESIEMENS HEALTHCARE GMBH2019-11-14
INGENIA 3.0TPHILIPS HEALTHCARE2019-11-08
SIGNA PIONEERGE MEDICAL SYSTEMS, LLC2019-11-07
SIEMENS AERA MRI SYSTEMSIEMENS MEDICAL SOLUTIONS USA, INC.2019-11-01
GE 1.5T SIGNA HDX MR SYSTEMGE MEDICAL SYSTEMS, LLC2019-10-30
ACHIEVA 1.5T NEWPHILIPS HEALTHCARE2019-10-29
INGENIA 3.0TPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.2019-10-21
INGENIA 1.5TPHILIPS HEALTHCARE2019-10-17
INGENIA ELITION XPHILIPS HEALTHCARE2019-10-16
MAGNETOM AERASIEMENS HEALTHCARE GMBH2019-10-15
GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEMGE MEDICAL SYSTEMS, LLC2019-10-14
MAGNETOM SKYRASIEMENS HEALTHCARE GMBH2019-10-14
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEMGE HANGWEI MEDICAL SYSTEMS CO., LTD.2019-10-09
DISCOVERY MR450W 1.5TGE MEDICAL SYSTEMS, LLC2019-10-03
MRISYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGEUNK2019-09-25
ACHIEVA XR 1.5T/3.0T NEWPHILIPS HEALTHCARE2019-09-25
INGENIA 3.0TPHILIPS HEALTHCARE2019-09-24

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